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Membrane Sweeping in Early Labor and Delivery Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03517696
Recruitment Status : Withdrawn (Study IRB approval expired)
First Posted : May 7, 2018
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Membrane sweeping is a routine procedure in obstetrics in term patients. It has been shown to be effective in decreasing post term gestation and in increasing rate of spontaneous vaginal delivery when used in setting of induction of labor in nulliparous patients. The goal of this study is to determine if membranes sweeping in early labor is effective in improving delivery outcomes including decreasing rate of cesarean section.

Condition or disease Intervention/treatment Phase
Early Labor Procedure: Membrane sweeping Not Applicable

Detailed Description:

This is a non-blinded randomized controlled trial. Participants will be recruited at time of presentation to triage for labor evaluation after cervical exam. Patients with a term, singleton pregnancy who present with regular, painful contractions and a Bishop score < 7 will be recruited to the study. A random number generator will be used to create a list of random binary numbers. If the patient agrees to the study, the random number list will be used to assign the participant to membrane sweeping or no membrane sweeping. Participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise. Those not assigned to membrane sweeping will not have an additional exam. Patients will then be managed as per their primary Obstetrics (OB) provider with the exception of no further membrane sweeping throughout the labor course.

Participants are only required to participate during initial evaluation and randomization. No extra study visits are required.

Due to the nature of the intervention, which requires a provider to perform a procedure, blinding will not be possible for this trial.

No therapy will be withheld for any patients. Their labor course will be managed as per their primary provider using standards of care.

Non-treatment group is necessary in order to exam the difference of effects between membrane sweeping and no membrane sweeping.

Patients will be removed from the study if they chose to withdraw their participation.

Participants will resume care as normal regardless of withdrawing study participation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-blinded Randomized Controlled Trial
Masking: None (Open Label)
Masking Description: Intervention is not able to be blinded
Primary Purpose: Treatment
Official Title: Membrane Sweeping in Early Labor and Delivery Outcomes
Actual Study Start Date : May 20, 2018
Actual Primary Completion Date : February 25, 2020
Actual Study Completion Date : February 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth

Arm Intervention/treatment
Active Comparator: Membrane Sweeping
Membrane sweeping
Procedure: Membrane sweeping
Participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise.

No Intervention: Control
Routine vaginal exam



Primary Outcome Measures :
  1. Decrease in Cesarean delivery rate [ Time Frame: Up to 3 weeks ]
    Decrease in Cesarean delivery rate


Secondary Outcome Measures :
  1. Time to delivery [ Time Frame: Up to 3 weeks ]
    Length of labor from randomization to delivery

  2. Operative vaginal delivery rate [ Time Frame: Up to 3 weeks ]
    Assess a decrease in operative vaginal delivery

  3. Labor augmentation rate reduction [ Time Frame: Up to 3 weeks ]
    Assess the reduction in the rate of labor augmentation ( via the use of oxytocin and/or amniotomy)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton pregnancy at or after 39 weeks gestation, intact membranes, cephalic presentation, nulliparous, Bishop score <7, English or Spanish speaking

Exclusion Criteria:

  • Prior uterine surgery precluding vaginal delivery, maternal condition precluding vaginal delivery, fetal anomaly, prior membrane stripping

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517696


Locations
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United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Jeanne S Sheffield, MD Johns Hopkins University
Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03517696    
Other Study ID Numbers: IRB00153394
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications